Clinical Trial Manager
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I have over ten years of progressive clinical research experience in global Phase I–III clinical trials, with a strong background in both clinical monitoring and clinical trial management across pharmaceutical-sponsored studies. I began my career as a Clinical Research Associate, where I conducted site monitoring visits, ensured compliance with ICH-GCP and regulatory requirements, reviewed essential documents, and supported site performance and data quality. This foundational experience gave me a strong understanding of site-level operations and clinical trial execution.
In my current role as a Clinical Trial Manager II, I lead the end-to-end management of global clinical studies from study start-up through database lock and study closeout. My responsibilities include supporting protocol development, vendor setup, site activation, and study initiation through First Patient In (FPI), as well as overseeing ongoing trial execution through Last Patient Last Visit (LPLV). I manage study timelines, CRO and vendor deliverables, site performance, and cross-functional communication while ensuring studies are conducted in compliance with SOPs, regulatory requirements, and quality standards.
Across my roles, I have developed strong expertise in stakeholder management, risk identification and mitigation, and ensuring inspection readiness. I collaborate closely with cross-functional teams including clinical operations, data management, regulatory affairs, and biostatistics, as well as external vendors and investigative sites. I am highly experienced in reviewing monitoring reports, tracking study metrics, and driving corrective actions to ensure high-quality data delivery and successful study outcomes in fast-paced global environments.